Plain English Summary
Background and study aims
Cellulite is a skin condition that can lead to skin imperfections, caused by uneven distribution of fat, It is seen most commonly in the thighs, hips and abdomen of both women and men. Exercise and a healthy diet can reduce the appearance of cellulite, but cannot completely eliminate it. Weight loss is key to reducing cellulite, whether this is achieved by diet or through exercising to burn calories and increase metabolism.
Herbal supplements can help to achieve weight loss faster than diet or exercise alone, as they increase the rate of burning fats. Some supplements containing compounds from plants can also help to reduce cellulite through removing toxins, draining fluids, reducing inflammation and firming and toning the skin, along with burning fat.
The aim of this study is to determine the efficacy of SelectSIEVE® Rainbow, a food supplement that contains a mixture of herbal and plant extracts including black rice, kiwi, orange and pineapple extract, on reducing the appearance of cellulite and on weight control.
Who can participate?
Healthy women aged 18-55 with cellulite and a BMI ranging from 23-30
What does the study involve?
Participants will be asked to take one capsule per day, containing either the food supplement (SelectSIEVE® Rainbow) or a placebo, for 56 days. Participants will be evaluated for changes in the appearance of their cellulite, skin elasticity and firmness, thickness of fatty layers and body measurements such as weight and circumferences. These measurements will be taken before starting the treatment, after 28 days and after 56 days. Participants will also be asked to take part in an interview for a self-assessment evaluation.
What are the possible benefits and risks of participating?
The possible benefit to participants is a reduction in the appearance of cellulite-related skin imperfections and a slimming effect. There are no known risks to participants, aside from a minimal risk of allergy or intolerance to the food supplement.
Where is the study run from?
Complife Italia S.r.l, Sam Martino Siccomario, Pavia, Italy
When is the study starting and how long is it expected to run for?
November 2017 to April 2018
Who is funding the study?
ROELMI HPC S.r.l (Italy)
Who is the main contact?
Dr Francesco Tursi
francesco.tursi@complifegroup.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr FRANCESCO TURSI
ORCID ID
http://orcid.org/0000-0002-0055-5925
Contact details
VIA GUIDO ROSSA 1
GARBAGNATE MILANESE (MI)
20024
Italy
+39 2 99025138
francesco.tursi@complifegroup.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
E.HU.039-0060.01.003L_2018/288
Study information
Scientific title
Randomized, double blind, placebo controlled clinical study for evaluating the efficacy of a food supplement on cellulite-derived skin imperfections and weight control
Acronym
Study hypothesis
The present study is aimed to assess the efficacy of food supplement based on a mixture of herbal extract (SelectSIEVE® Rainbow), in ameliorating cellulite-derived skin imperfections as well as on the weight control.
Ethics approval
Independent Ethical Committee for Non-Pharmacological Clinical Study Trials, 02/02/2018, ref 2018/01
Study design
Interventional double-blind placebo-controlled single-centre parallel group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Cellulite-derived skin imperfections and localised adiposity at level of thighs/hip/waistline
Intervention
60 healthy female participants were randomly allocated evenly into either the treatment or placebo group using a computer generated restricted randomisation list. Participants in the treatment group took capsules containing the active product (SelectSIEVE® Rainbow), a food supplement containing a mixture of herbal extracts, maltodextrins and natural dye. Participants in the placebo group took placebo capsules, where the active product was substituted by maltodextrins. Both groups took 1 capsule per day with a drink of water, either before lunch or their main meal, for 56 days. Participants in both groups were asked to follow a personalised alimentary diet, calculated in order to reduce their daily calorie intake by 300 kcal. Participants were also asked to use a body cream in place of their standard cream for body care.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
The following outcomes were measured at day 0 (beginning of the treatment), day 28 and day 56 of treatment:
1. Cellulite-induced alteration of the skin microcirculation, measured by thermographic imaging
2. Clinical-dermatological evaluation of the cellulite-derived skin imperfections ("Orange peel" skin appearance ) carried out by a dermatologist in accordance to clinical scores
3. Thickness of the subcutaneous fatty layer measured by an ultrasound technique (using BX2000 BodyMetrix)
4. Skin elasticity and firmness, measured on the thighs by a Cutometer®
Secondary outcome measures
The following outcomes were measured at day 0 (beginning of the treatment), day 28 and day 56 of treatment:
1. Body weight by electric balance and height by stadiometer (for BMI determination)
2. Body circumferences (tights, hips, waistline) by a flexible meter
3. Evaluation of safety (adverse effects and tolerability) by monitoring adverse effects
4. Self-assessment evaluation, assessed using a 12 question questionnaire carried out after 28 and 56 days of treatment
Overall trial start date
10/11/2017
Overall trial end date
03/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Good general health
2. Female
3. Caucasian ethnicity
4. Age between 18 and 55 years old
5. Mild to moderate cellulite-derived skin imperfections (grade II and III of the cellulite thermographic stage)
6. BMI between 23 and 30.
7. Not been recently involved in any other similar study
8. Willing to follow the proposed alimentary diet for all the study time
9. Willing to use only the cream consigned at the beginning of the study for body care
10. Willing to submit to before and after pictures
11. Willing to use only the food supplement during the entire study period
12. Willing to not use products likely to interfere with the food supplement
13. Willing to not vary the normal daily routine (i.e. lifestyle, physical activity, etc.)
14. Under effective contraception (oral/not oral) that is not expected to be changed during the trial
15. Aware of study procedures and signed informed consent form
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
1. Pregnant or intending to become pregnant during study
2. Breastfeeding
3. Atopy (if this interferes with the study)
4. Allergic to ingredients of food supplements
5. Allergies to cosmetic products, toiletries, sunscreens and/or topical drugs
6. Following anti-cellulite treatment or have followed an anti-cellulite treatment less than 3 months before the study
7. Used sunbeds or self-tanning product for one month before study or intend to use it during the study
8. Using pharmacological treatment (local or systemic) that may interfere with study
9. Intending to initiate any intensive sport
10. Other diseases that may affect outcome of study, especially metabolic or endocrine (e.g. diabetes, liver disease, kidney disorders) or any other condition that the principal investigator deems inappropriate for participation
11. Protected by the law (under guardianship, hospitalised in a public or private institution or incarcerated)
12. Unable to communicate or cooperate with the investigator
Recruitment start date
05/02/2018
Recruitment end date
07/02/2018
Locations
Countries of recruitment
Italy
Trial participating centre
Complife Italia Srl
Via Mons. Angelini 21
San Martino Siccomario (PV)
27028
Italy
Sponsor information
Organisation
ROELMI HPC Srl
Sponsor details
Via Celeste Milani 24
ORIGGIO (VA)
21040
Italy
Sponsor type
Industry
Website
Funders
Funder type
Not defined
Funder name
ROELMI HPC Srl
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Data will published in relevant international peer reviewed journals.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository on a proprietary server. Tables and pictures will be shared and will become available after editing and sending the final report to the sponsor. Datasets will be available for 10 years. The prinicipal investigator and control authorities (on request) can access data for analyses including anthropometric measures, calculations and pictures. Access will be granted via a personal password. Consent from participants was obtained and all data is anonymised through coding. There are no ethical or legal restrictions.
Intention to publish date
31/12/2018
Participant level data
Stored in repository
Basic results (scientific)
Food supplement group showed a significant amelioration of all parameters in respect to the basal values. furthermore, a statistically significant variation in respect to the dummy group was achieved by the group treated with SelectSIEVE® Rainbow
Publication list